Does IV Ondansetron Prevent Pruritus After Intrathecal Morphine in Pediatric Patients?

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Pruritus, Nausea/Vomiting

In brief

This is a prospective randomized, double-blind, placebo-controlled study to compare the incidence and intensity of ITM-induced pruritus and nausea/vomiting using pre-emptive IV ondansetron, followed by scheduled Around The Clock (ATC) ondansetron vs. our control group, where pruritus and PONV are treated with PRN only medications.

Key facts

Study ID

NCT03262038

Run by

University of Michigan

People needed

46

Starts

2017-12-07

Expected to finish

2019-08-20

Last updated by the study team

2021-01-19

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 3-17 years
• weight </= 100kg
• scheduled for urologic or orthopedic procedure necessitating intrathecal morphine
• ability to use verbal or pictorial pain assessment tools and techniques
• informed consent and (if applicable) assent

You may not qualify if…

• Inability to use verbal or pictorial pain scoring scales
• hypersensitivity to selective 5-HT receptor antagonists
• diagnosed congenital long QT syndrome
• severe hepatic impairment
• pregnancy or nursing mothers

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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